Rapid Micro Methods News

Our news pages will keep you informed of press releases and news articles on RMM technologies, updates from technology suppliers, reviews of recent publications and presentations, and what's changing in the world of rapid methods. You can also follow our news posts on Twitter, Facebook, LinkedIn and RSS.

Sunday, March 29, 2015

A rapid Ebola diagnostic kit similar to a pregnancy kit has been developed by British military scientists and NHS medics in Sierra Leone.

It can be administered at the bedside and return its first results within 20 minutes, slashing dramatically the normal 24-hour turnaround for lab results.

Early bedside tests in the Connaught hospital in Freetown have shown a 100% detection rate, said Dr Oliver Johnson, who heads a partnership between the UK’s King’s Health Partners and the hospital.

“We have 10,000 of these kits sitting in Sierra Leone waiting to go if we can get the approval,” says Johnson.

Johnson says if the kit is approved by the relevant health authorities it could transform the admissions process, allowing doctors to quickly isolate Ebola patients and release others for treatment.

“It would mean patients who don’t have Ebola could be prioritised and go straight to surgery or referred for further treatment to general wards. Ebola symptoms are so similar to other illnesses like malaria, even appendicitis,” he said.

It would also help in ruling out Ebola in women who are about to give birth, which would reduce the perceived risk in obstetric deliveries, Johnson said.

The kit has been developed by the UK’s defence, science and technology lab and been tested by Kings Sierra Leone Partnership (KSLP).

It works in the same manner as a urinary pregnancy test, with a drop of blood drawn across some filter paper.

KSLP says it is similar to a antigen rapid test recently approved by the World Health Organisation, but early tests show it outperforms with a “sensitivity of 100%” according to a research paper published on Friday by Eurosurveillance.

All equipment for the rapid diagnostic test (RDT) was provided in individually packaged test kits. Capillary blood for the RDT was obtained using a sterile lancet to prick a finger. Blood was applied to the well of the lateral flow device with a small pipette, followed by three drops of buffer. After 20 minutes the RDTs were read in designated areas with good lighting and scores were obtained with the aid of a scorecard.

Although the numberof Ebola cases was down to 33 in the last week of official figures compared to more than 550 at its peak in November, it remains a huge concern in the country.

“Frankly, until we have zero cases for 42 days we can’t say it’s been eliminated. The country is still like dry tinder in terms of a spark going off,” said Johnson.

He said a lockdown in the country is designed to “keep the public focussed” on the possible dangers. With the falling figures there is risk of growing complacency, the government has said.

In one recent case a fisherman escaped from a quarantined area in Freetown and returned to his family in rural Sierra Leone, causing 31 new infections.

The Ministry of Defence announced on Friday that the Royal Fleet Auxillary ship, Argus, was returning to the UK six months after it arrived in Freetown to offer logistical support involving helicopters and royal marines.

Some 300 military personnel will remain in Sierra Leone including logisticians, planners and medics.

The IMI, through its Ebola+ programme, will fund PHE with a 1 million pounds grant to coordinate a consortium, called MOFÍNA, of European public and private sector scientists to develop and validate a new test for Ebola, which it is hoped will let medical workers diagnose patients on site.

The research team aims to develop and validate a molecular point of care (POC) system suitable for safe, specific and sensitive detection of Ebola virus infection within the field. The system is based on the existing CE-marked assay marketed by altona and an integrated molecular diagnostic platform from Alere Inc. This molecular point of care system will detect the genetic material of Ebola viruses at a sensitivity and specificity comparable with test systems performed at central laboratories.

Professor Miles Carroll, Head of Research, Microbiology Services for PHE, said:

"If our research is successful, it could be possible to diagnose a suspected case on site in 30 to 40 minutes, which will dramatically decrease mortality rates.

"Patients will be treated faster leading to a greater chance of their survival. It will also help medical staff stop the spread of infection and ultimately bring outbreaks to an end."

Chief Medical Officer Dame Sally Davies said:

"A rapid diagnostic test has the potential to reduce the devastating effects of Ebola that have affected West Africa during the recent outbreak. This is a fantastic opportunity for Public Health England to significantly improve how we treat Ebola patients and ultimately stop the spread of the virus."

Dr Seshadri Vasan, PHE's business lead for the project, said:

"There is a need for rapid, accurate Ebola tests that can be used on site. We're aiming to develop a test that can be administered safely and used in locations where laboratories are unavailable.

"Our Public Health England scientists are on the front lines in West Africa, working with academic and private sector partners from around the world to develop therapeutic and diagnostic options for Ebola.”

Conventional methods for testing food-borne pathogens is based on the cultivation of pathogens, a process that is complicated and time consuming. So there is demand for alternative methods to test for food-borne pathogens that are simpler, quick and applicable to a wide range of potential applications.

Now Toshiba Ltd and Kawasaki City Institute for Public Health have collaborated in the development of a rapid and efficient automatic abbreviated DNA detection technology that can test for 14 major types of food borne pathogens. The so called 'DNA chip card' employs electrochemical DNA chips and overcomes the complicated procedures associated with genetic testing of conventional methods. The 'DNA chip card' is expected to find applications in hygiene management in food manufacture, pharmaceuticals, and cosmetics.

The so-called automatic abbreviated DNA detection technology 'DNA chip card' was developed by Toshiba Ltd and in a collaboration with Kawasaki City Institute for Public Health, used to simultaneously detect 14 different types of food-borne pathogens in less than 90 minutes. The detection sensitivity depends on the target pathogen and has a range of 1E+01~05 cfu/mL.

Notably, such tests would usually take 4-5 days using conventional methods based on pathogen cultivation. Furthermore, in contrast to conventional DNA protocols that require high levels of skill and expertise, the 'DNA chip card' only requires the operator to inject nucleic acid, thereby making the procedure easier to use and without specialized operating skills.

Examples of pathogens associated with food poisoning that were tested with the "DNA chip card”

Antibiotics save millions of lives every year. Today, however, the emergence of drug resistance in bacteria is undermining the effectiveness of current antibiotics and our ability to treat and prevent disease. The Centers for Disease Control and Prevention (CDC) estimates that drug-resistant bacteria cause two million illnesses and approximately 23,000 deaths each year in the United States alone. Antibiotic resistance also limits our ability to perform a range of modern medical procedures, such as chemotherapy, surgery, and organ transplants. That’s why fighting antibiotic resistance is a national priority.

Over the past year, the Administration has taken important steps to address the threat of antibiotic resistance. In September 2014, the President issued Executive Order (EO) 13676: Combating Antibiotic-Resistant Bacteria, which outlines steps for implementing the National Strategy on Combating Antibiotic-Resistant Bacteria and addressing the policy recommendations of the President’s Council of Advisors on Science and Technology (PCAST)’s report on Combating Antibiotic Resistance. Furthermore, the President’s FY 2016 Budget released earlier this year proposed nearly doubling the amount of Federal funding for combating and preventing antibiotic resistance to more than $1.2 billion.

Combating and preventing antibiotic resistance, however, will be a long-term effort. That’s why, today, the Administration is releasing the National Action Plan for Combating Antibiotic Resistant Bacteria (NAP). The NAP outlines a whole-of-government approach over the next five years targeted at addressing this threat:

1. Slow the emergence of resistant bacteria and prevent the spread of resistant infections

The judicious use of antibiotics in health care and agriculture settings is essential to combating the rise in antibiotic resistance. We can help slow the emergence of resistant bacteria by being smarter about prescribing practices across all human and animal health care settings, and by continuing to eliminate the use of medically-important antibiotics for growth promotion in animals.

2. Strengthen national "One-Health" surveillance efforts

A “One-Health” approach to disease surveillance will improve detection and control of antibiotic resistance by integrating data from multiple monitoring networks, and by providing high-quality information, such as detailed genomic data, necessary to tracking resistant bacteria in diverse settings in a timely fashion.

3. Advance development and use of rapid and innovative diagnostic tests

The development of rapid “point-of-need” diagnostic tests could significantly reduce unnecessary antibiotic use by allowing health care providers to distinguish between viral and bacterial infections, and identify bacterial drug susceptibilities during a single health care visit making it easier for providers to recommend appropriate, targeted treatment.

4. Accelerate basic and applied research and development

New antibiotics and alternative treatments for both humans and animals are critical to maintaining our capacity to treat and prevent disease. This involves supporting and streamlining the drug development process, as well as increasing the number of candidate drugs at all stages of the development pipeline. Additionally, boosting basic research to better understand the ecology of antibiotic resistance will help us develop effective mitigation strategies.

5. Improve international collaboration and capacities

Antibiotic resistance is a global problem that requires global solutions. The United States will engage with foreign ministries and institutions to strengthen national and international capacities to detect, monitor, analyze, and report antibiotic resistance; provide resources and incentives to spur the development of therapeutics and diagnostics for use in humans and animals; and strengthen regional networks and global partnerships that help prevent and control the emergence and spread of resistance.

The NAP is a comprehensive effort that will require the coordinated and complementary efforts of individuals and groups around the world, including public- and private-sector partners, health care providers, health care leaders, veterinarians, agriculture industry leaders, manufacturers, policymakers, and patients. Working together, we can turn the tide against the rise in antibiotic resistance and make the world a healthier and safer place for the next generation.

Wednesday, March 25, 2015

Immunetics, an immunological and molecular diagnostic testing firm, has begun working under a new Phase II SBIR grant awarded this January to clinically validate a PCR amplification- and array hybridization-based test for about 30 fungal pathogens.

The funding, a total of $3 million over three years from the National Institute of Allergy and Infectious Diseases, will support the final steps of development and optimization, as well as both retrospective and clinical validation of the assay with two academic medical centers, Andrew Levin, Immunetics' president and CEO, told GenomeWeb this week.

Using the data collected in its clinical validation — which should be complete by the end of the three-year grant period — the company then plans to submit the assay for approval by the US Food and Drug Administration.

"This would be the first product of this type that the FDA would approve," Levin said.

According to Levin, as the population of patients susceptible to severe fungal infection — mainly those who are immunosuppressed or immunocompromised due to transplantation, cancer treatment, or diseases like HIV — has grown, so has a recognition that the field requires much better tools for diagnosis than traditional culture methods.

"Fungal pathogens have been sort of a backwater for many years … but it's becoming more recognized and has emerged as a field that really needs and deserves a lot more medical attention," he said.

Immunetics is not the only company or group heeding this call. For example, a team from the University of Texas Health Science Center in San Antonio last year published a new method for extraction and amplification of fungal DNA for sequence-based identification of fungi.

Commercial products aimed at diagnosing infectious pathogens in cases of sepsis also frequently include a handful of fungal species, Levin said. For example, T2 Biosystems has seen success with its sepsis assay focused specifically on Candida.

Meanwhile, Abbott is continuing to develop its Iridica platform (previously Plex-ID), which includes a panel to differentiate 200 families of fungi. The Iridica system, however, requires a large, relatively expensive instrument, and is available for research use only in the US.

According to Levin, there has yet to be a technology commercialized for clinical use in the US that offers rapid identification of a broad range of fungal species without an expensive instrumentation requirement, and Immunetics hopes its assay will fill this unmet need.

"The fact that T2 has made such an impact suggests that there really is a need here. We wanted to look beyond Candida, which is fairly common, to develop a panel that would allow detection of a broad range of these esoteric pathogens in one fell swoop," he said.

According to the Immunetics' grant abstract for its new second phase of funding, the company's fungal infection test relies on PCR amplification followed by hybridization on a microarray using species-specific probes.

"The uniqueness of the assay is really the combination of our primer sequences, which are aimed at amplifying a broad range of fungi, and these species-specific probes that allow us to identify a range of different species very specifically," Levin explained.

"The array is built on the use of these species-specific probe sequences, which allow us to do a single amplification and then identify what is amplified among these targets," he said.

According to Levin, Immunetics is still working on final development steps for the assay.

"We have some time ahead of us to finish developing the product to the point where it can be put in someone else's lab," he said. "We are still working on the instrument format, but we are aiming at something that will be very available and accessible to users — not requiring something too sophisticated or exotic."

According to the company, the assay is expected to have an approximately five-hour turnaround time.

Once the test is solidified enough to be used in outside labs, the company will begin its clinical validation, working with partners in two large clinical centers that see significant numbers of fungal infection patients.

"When we get to the right point they will help us with validation of the assay in real time – on actual patient populations," Levin said. "The aim is to take the prototype assay we developed in phase I and fully develop it as a commercial product."

This validation study will likely begin in the second and third year of the company's Phase II funding, and will finish by the end of the three-year grant, enabling Immunetics to then submit the assay to the FDA.

Cepheid announced it has received Emergency Use Authorization from the U.S. Food & Drug Administration (FDA) for Xpert® Ebola, a molecular diagnostic test for Ebola Zaire Virus that delivers results in less than two hours. The test runs on the Cepheid GeneXpert® Systems, the world's leading molecular diagnostic platform with over 8,000 systems deployed globally in both developed and emerging market countries.

Ebola was first discovered in 1976 near the Ebola River in what is now the Democratic Republic of the Congo. Since then, outbreaks have appeared sporadically in Africa. The 2014 Ebola epidemic is the largest in history, affecting multiple countries in West Africa. In the United States four cases have been reported: two imported cases that included one death, and two locally acquired cases in healthcare workers.

"We developed Xpert Ebola with a dual-target design to ensure high-accuracy and sensitivity for detecting the Ebola Zaire virus, detected in the West Africa outbreak in 2014. The test runs in Cepheid's self-contained cartridge to minimize potential contamination," said John Bishop, Cepheid's Chairman and CEO. "Cepheid has historically played a leading role in developing molecular diagnostics as an aid to infection control efforts, and the current Ebola crisis represents an extreme example of the need for sensitive, fast, and easy to use diagnostics to aid in patient management and isolation requirements. We believe this is a major step in strengthening the arsenal of tools being deployed to address the current situation."

On August 5, 2014 the U.S. Secretary of Health and Human Services declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus. Cepheid's Xpert Ebola has not been FDA cleared or approved, but will remain available in the U.S. as an EUA product as long as the declared emergency remains in effect or it ceases to be authorized by FDA.

"With support from the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation (provided via the National Philanthropic Trust Fund for Global Health and Development), Cepheid was able to leverage its extensive development experience to expedite delivery from the initial prototype to an emergency use only product in just 90 days," said David Persing, MD, Ph.D., Cepheid's Chief Medical and Technology Officer. "We expect that this technology will help to expedite the evaluation of suspected cases and to enable more effective field surveillance activities already underway in endemic areas."

Xpert Ebola has been authorized by FDA under an Emergency Use Authorization for use by CLIA moderate and high complexity laboratories or similarly qualified non-U.S. laboratories.

Monday, March 23, 2015

More than a quarter of multi-drug resistant tuberculosis (MDR-TB) strains isolated in a national survey in Swaziland carry a mutation that is undetectable by the advanced rapid molecular diagnostic tests currently in widespread use, according to a letter published in the New England Journal of Medicine by Doctors Without Borders/Médecins Sans Frontierès (MSF) and the Research Center in Borstel, Germany, this week.

Rapid molecular tests such as the WHO-recommended XpertMTB/RIF assay are the first-line method for identifying cases of MDR-TB and controlling the spread of the disease in Swaziland, the country with the world’s highest TB prevalence.

“These diagnostic tests are our front line of defense in fighting drug-resistant TB,” said Alex Telnov, HIV/TB referent at MSF. “Accurate, rapid test results mean that we can start people on treatment that targets the specific strain they are infected with, which in turn increases their chances of survival and helps prevent transmission of drug-resistant infections. To learn that we could be missing so many cases means there is an urgent need to adapt our detection approach to MDR-TB in Swaziland.”

Epicentre, an MSF-affiliated research center, together with the Research Center in Borstel, Germany, analyzed TB strains collected in 2009-2010 during the most recent national TB drug resistance survey in Swaziland. A genotyping analysis found that 30 percent of the 125 MDR-TB strains recovered from the survey carry a specific genetic mutation, called rpoB (I491F), that had been identified previously in rare strains from Hong Kong and Australia.

This mutation is not only resistant to the key first-line TB drug, rifampicin (RIF), but is undetectable by the XpertMTB/RIF assay. This assay is used throughout most of Swaziland as the standard screening test for TB and MDR-TB, as per WHO recommendation.

"The high proportion of the circulating strain with I491F mutations poses a significant public health challenge that must not be ignored," said Stefan Nieman, at Research Center Borstel and the German Center for Infection Research. "By missing these diagnoses of drug resistance and therefore under-treating patients, the likely consequence is further transmission of this difficult-to-treat strain."

The results of the analysis are particularly problematic in a country where 26 percent of adults have HIV (the world’s highest prevalence), and 80 percent of TB patients are co-infected with HIV. This is especially worrying in Swaziland, where the 2009-2010 survey showed that TB patients who also have HIV are more likely than those who are HIV-negative to be infected with MDR-TB.

As a result of this new research, MSF recommends that all patients in Swaziland who have tested positive for TB but who test negative for drug resistance with the XpertMTB/RIF test undergo additional drug susceptibility testing. It is also essential to conduct studies that can determine whether this rpoB (I491F) mutation is present in neighboring countries such as South Africa or Mozambique.

"If we’re facing wide distribution of this strain in Southern Africa or elsewhere, it is imperative that the rapid molecular tests we currently use, as well as those under development, be adapted to detect a wider range of mutations," said Maryline Bonnet, researcher at Epicentre.

MSF has been present in Swaziland since 2007 to support the Ministry of Health in fighting the dual epidemics of HIV and TB in the small landlocked kingdom. Swaziland has the highest estimated HIV prevalence in young adults (26 percent of 15-49 years old), and the highest estimated TB incidence rate (1,350/100,000 per year) and a co-infection rate of 74 percent.

In 2014, a total of 904 patients were put under TB treatment at MSF facilities. Out of 77 patients enrolled for DRTB treatment, 57 of them were MDR-TB patients.

Friday, March 20, 2015

Results of a recent study have shown that the BioFire FilmArray Respiratory Panel (RP) detects one third fewer cases of Bortedella pertussis, the causative agent of whooping cough, when compared to standard PCR-based assays.

However, representatives at BioFire, a BioMérieux subsidiary, told GenomeWeb that this result was not unexpected, and the more specific target in its test has the advantage of reducing the number of false positive results.

Kristen Kanack, BioFire’s VP of regulated products and clinical affairs, and Mari Hoidal,director of marketing, spoke to GenomeWeb about the new study, published online last week in the Journal of Clinical Pathology.

In developing the panel, the firm chose to "provide the most specific assay we could, with the least probability of false-positive results due to contamination," Kanack asserted.

As opposed to testing for an insertion gene called IS481, which can be present in up to 200 copies per bacterium as well as in lower numbers in related Bordetella strains, BioFire chose as its target the promoter for the B. pertussis toxin gene, which is present in one copy per genome.

Hoidal affirmed that the panel has so far met with approval of customers. "The [RP] panel has been a huge success for us and continues to be a major bread-winning product," she added.

The panel runs on the FilmArray platform, which is an automated, multiplexed testing system that uses PCR and melt-curve analysis to detect infectious agents in about an hour. A 2.0 version of the platform was cleared by the US Food and Drug Administration last month.

In general, PCR testing for pertussis is rapid and sensitive, but the lack of standardization and variable specificity is a concern, according to a 2013 review.

High sensitivity can lead to false positive results, while high specificity can lead to false negative results. Molecular diagnostics makers balance the pros and cons of these outcomes in different ways, depending on the market and health consequences of the test results. With testing for human papillomavirus as a cervical cancer screen, for example, the debate seems to be settling in favor of false positives, despite objections of firms who make more sensitive or more general tests, as previously reported. In non-invasive prenatal testing, however, false positive results, which may have rates as high as 50 percent, could possibly result in termination of healthy pregnancies.

The JCP study of FilmArray RP was conducted by researchers at Children's Healthcare of Atlanta and Emory University, two of whom have served on advisory boards for BioFire and also perform research and development with the FilmArray instrument, according to a competing interests statement in the study.

"The conundrum related to PCR testing for B. pertussis revolves around whether the assay implemented in a clinical laboratory should be highly sensitive (IS481 target) or highly specific (pertussis toxin gene target)," the researchers wrote.

The researchers initially ran a standard PCR-based test from Focus Diagnostics on a set of clinical samples consisting of flocked swabs from patients aged one month to 18 years old.

These samples were originally tested about two years prior to FilmArray testing and then frozen in universal transport medium. The first step was to thaw and retest all the 74 positive samples with the Focus assay. Three samples associated with high Ct values did not repeat as positive results.

In the remaining cohort of 71 positives by Focus PCR, 25 were discrepant for the FilmArray RP. These 25 samples were then sent to the US Centers for Disease Control and Prevention and re-tested using their assay for B. pertussis and B. holmesii, a related bacterium that also happens to carry the IS481 insertion repeat.

The CDC concluded two of the samples did not have B. pertussis, and thus could be called false-positive in the Focus test. Meanwhile, of the 23 samples positive for the IS481 target, 10 also had the toxin gene target, and were considered pertussis-positive. The remaining 13 were considered intermediate, while B. holmesii was not detected in any of the 25 samples.

One of BioFire's considerations in designing the panel was reports of so-called pseudo-epidemics of pertussis, Kanack explained.

A 2010-2011 outbreak in Ohio, for example, later turned out to be a mixed outbreak of B. pertussis and B. holmesii. The IS481 element is also present in B. bronchiseptica strains, she said.

Another concern was contamination of otherwise negative samples. Because the IS481 element is present in such high numbers per cell, even a tiny amount of contamination could register as a positive result.

An apparent outbreak in a rural part of Colorado may have been the result of "environmentally present B. pertussis DNA in clinics from vaccine, clinic standard specimen collection practices, use of liquid transport medium, and lack of clinically relevant PCR cutoffs," according to a subsequent analysis in Pediatrics. And an outbreak of PCR-detected "atypical pertussis" among pre-schoolers in Toronto in 2009 was attributed in part to transient nasopharyngeal B. pertussis carriage.

On the other hand, last year an Archives of Pathology study of the impact of the FilmArray RP assay on patient outcomes showed that it "decreases the duration of antibiotic use, the length of inpatient stay, and the time in isolation." Authors of that work include two of the co-authors of the recent JCP evaluation.

BioFire provided materials for the research, and, although two of the researchers were part of the company's scientific advisory boards, Kanack emphasized that the current study was independent. "We collaborate with many people helping to advise us on our panel," she said.

"A lot of thought was put into this, and we stand by the decision for this panel," Kanack said. However, she added, "we are always listening to our customers and new developments in the field, and are open to considering any of our decisions."

Furthermore, BioFire has been aware of the possible disadvantages of a more specific pertussis target for some time, and issued an advisory notice in May of 2013.

"We put it out just for some clarification, although similar information is already included in our packaging," said Kanack.

The CDC guidelines for PCR assays of pertussis note that "IS481 is especially susceptible to falsely-positive results," and points out that "clinical laboratories might report high Ct values as any of the following: positive, detected, indeterminate, or equivocal." In the current study, for example, CDC re-tested samples that were IS481 positive but those negative for the toxin gene were "deemed intermediate."

"Intermediate or indeterminate pretty much mean that there is an element of IS481 that was detected, but it is not confirmed that it is from a pertussis [bacterium]. It could be, but it could not be as well," Kanack said.

The CDC further advises that "interpretation of PCR results, especially those with high Ct values, should be done in conjunction with an evaluation of signs and symptoms and available epidemiological information."

BioFire currently manufactures three FDA-cleared panels. Its respiratory panel was cleared to test for 15 organisms in 2011, when the company was called Idaho Technology, and later granted 510(k) clearance for five additional pathogens. The firm also has FDA-cleared panels for blood culture identification and gastrointestinal infections.

Hoidal said the firm has a lower respiratory panel in development and a meningitis panel that is nearing readiness for FDA submission. The firm's sister company, BioFire Defense, has two Ebola assays on the FilmArray platform which are still available under Emergency Use Authorization.

BioMérieux's $486 million acquisition of BioFire in January 2014 contributed to an annual earnings increase, and BioMérieux expects BioFire to "expand quickly" in the US, led by its FilmArray panels, as previously reported.

Researchers at the Johns Hopkins Bloomberg School of Public Health have been awarded a $525,000 grant from the Bill & Melinda Gates Foundation to evaluate a promising technology that detects malaria parasites in saliva before individuals get sick and become carriers of the parasite. The team, part of the Johns Hopkins Malaria Research Institute, will work with the biotech firm Ceres Nanosciences to assess a sampling platform developed by Ceres.

Despite progress in the campaign to eliminate the mosquito-borne illness, malaria still sickens an estimated 200 million people a year and kills an estimated 600,000 of them, mostly children under the age of five. Non-invasive tests that do not require needles and/or lab work -- the way many blood tests do -- and can provide rapid diagnosis are seen as a critical step in reducing first-time malaria cases and blocking transmission by those who have recovered but still carry the parasite. Malaria is most successfully treated when caught early.

Preliminary research suggests there is a new set of malaria biomarkers present in saliva, which could identify a larger population of malaria carriers than previously estimated. The Ceres test uses its Nanotrap® particle technology to sample and enrich saliva to identify the presence of the malaria biomarker. During a six-month evaluation, the Hopkins team will work with Ceres to evaluate whether the biomarker can increase the percentage of asymptomatic carriers of malaria who can be correctly diagnosed.

In their assessment, researchers will compare the concentration of biomarkers in blood and saliva and also between symptomatic and asymptomatic carriers. A variation of this test could also be used to diagnose first-time malaria cases. The test would thus lead to faster treatment for those cases as well as stave transmission.

“This platform could present a very compelling solution for rapid identification of infected individuals who may otherwise go undetected,” says Rhoel Dinglasan, PhD, the principal investigator and an assistant professor in the Bloomberg School’s Department of Molecular Microbiology and Immunology. “If the test proves effective, it could meet an unmet public health need, and fill a critical gap in our knowledge by enabling the identification of asymptomatic individuals who contribute to malaria transmission.”

An inexpensive rapid diagnostic test could be used to assess children and adults in large-scale screenings in settings such as schools and community centers. Those who tested positive would receive antimalarials, which could greatly reduce an infection source.

Ceres’ Nanotrap® technology was invented at George Mason University with funding from the National Institutes of Health (NIH), and currently is being developed into commercial products by Ceres with continuing support from NIH and other agencies.

The Tyndall Institute in Cork is working with Teagasc to create a biosensor device to prevent harmful bacteria from entering the dairy supply chain. Fifteen per cent of the world's infant milk formula is produced in Ireland.

The new system will revolutionise quality monitoring processes within the dairy industry at a global level, benefiting businesses and consumers.

Ireland is responsible for 15pc of the world’s infant milk formula and removal of milk quotas in 2015 ensures global impact.

The Department of Agriculture, Food and Marine will provide €625,000 in funding under its FIRM programme.

The first of its kind, the project will develop a portable biosensor to detect spore forming harmful bacteria of environmental origins that may enter the dairy supply chain and exceed the ever-tightening microbiological specifications for high-end products such as infant milk formula.

The Tyndall Teagasc project, under the ‘Spore Analysis Critical Control Point’ (SACCP) partnership, will look to create a biosensor that will allow on-site, in-line and real-time testing of milk to ensure that harmful spore-forming bacteria, which can survive pasteurisation, do not reach harmful levels.

Current spore detection processes are cumbersome and can take days of analysis in laboratories before establishing a definitive result. By comparison, the biosensor under development will be portable and produce results in just minutes.

A battle against time itself

“This biosensor has the potential to become an essential component of the dairy manufacturing process all over the world,” said Dr Karen Twomey of Tyndall.

“Early detection is key and the biosensor will enable producers to take preventative measures at earlier stages thus preventing unnecessary product downgrade.

“This technology is also incredibly flexible and can be modified to detect a range of other bodies enabling it to be used across other areas of the food industry and other sectors such as environment, security and medical to name but a few. This is currently the only research of its kind taking place so we have a real opportunity to create an important tool that will not only benefit businesses but also consumers all over the world.”

Teagasc’s project coordinator Dr Phil Kelly said that there is an urgent need in dairy food manufacturing for the creation of such a biosensor.

He said the biosensor will give a rapid indication of the presence of sporeforming bacteria and enable early intervention process control strategies to be implemented.

“The Teagasc microbiological and technological tasks running in tandem throughout the project will provide a platform for early prototype testing and biosensor calibration,” Dr Kelly said.

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced Tuesday that it has received clearance from the United States Food and Drug Administration (FDA) to market its AmpliVue Trichomonas Assay for the detection of nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic female patients. This molecular assay aids in the diagnosis of trichomoniasis, a sexually transmitted disease attributable to infection by the Trichomonas vaginalis parasite.

According to the Centers for Disease Control and Prevention (CDC), an estimated 3.7 million people in the United States have trichomoniasis. This disease is more common in women and, because only about 30% of those infected develop symptoms of trichomoniasis, most infected persons do not know that they carry the parasite.1 For pregnant women, Trichomonas infection is often associated with preterm delivery and low body weight in newborns. Genital inflammation is often associated with disease and can facilitate infection by other sexually transmitted pathogens, including HIV. Importantly, trichomoniasis can be cured with a single dose of antibiotics, emphasizing the need for rapid, highly sensitive tests that can detect this parasite and prompt immediate treatment.

The AmpliVue Trichomonas Assay is an easy-to-use, self-contained, handheld disposable molecular diagnostic test with superb clinical accuracy and with procedural steps consistent with those commonly seen in moderately complex laboratories. The assay requires no upfront extraction of DNA and generates an accurate result in approximately 50 minutes. Like other previously FDA-cleared AmpliVue assays, the AmpliVue Trichomonas Assay does not require the customer to invest in either expensive thermocycling equipment, or any other upfront testing costs. It is anticipated that minimal training will be required, as is the case with Quidel’s other five in vitro diagnostic assays that use the AmpliVue platform. Using AmpliVue can therefore significantly lower a laboratory’s cost to adopt and maintain the assay’s unique molecular testing methods.

“Our AmpliVue Trichomoniasis Assay has shown excellent performance with samples from both symptomatic and asymptomatic patients. We believe that our test will play a critical role in quickly diagnosing this disease, creating opportunities for patient treatment and thereby limiting its spread,” said Douglas Bryant, president and chief executive officer of Quidel Corporation.

Quidel’s AmpliVue platform now enables laboratories of all sizes to perform highly sensitive and specific molecular tests. The AmpliVue Trichomonas Assay is Quidel’s sixth molecular infectious disease assay to receive 510(k) clearance from the FDA in this hand-held, disposable AmpliVue format. In addition to Trichomonas, Quidel offers 510(k)-cleared, in vitro diagnostic products on this novel platform for the diagnosis of six other pathogens: C. difficile, Group A Strep, Group B Strep, Pertussis, HSV1 and HSV2.

San Francisco General Hospital is taking a stab at lowering The City’s steady rate of tuberculosis patients with a new genetic test.

Last month, the hospital became the first in California to pilot the diagnostic test, which reduces the need to isolate suspected patients and speeds up the administration of treatment, doctors said during a demonstration of the test Wednesday.

The test detects DNA sequences from the bacteria that causes tuberculosis using a patient’s specimen and delivers the results in two hours, said Dr. Barbara Haller, chief of microbiology at SFGH. Diagnosis using the more traditional test can take up to two weeks.

Tuberculosis is spread when a contagious person with an active form of the disease coughs the bacteria into the air, which can stay in the immediate atmosphere for hours if there is no ventilation or sunlight.

The disease is curable, but can be deadly. In California, where 23 percent of U.S. cases are found, it kills about one in 10 patients.

San Francisco has one of the highest rates of tuberculosis in the U.S. and the second-highest in the state. The City recorded 114 cases in 2014 and 107 in 2013.

The numbers have remained high in part because The City’s population has connections to countries with elevated rates of tuberculosis, particularly in Asia, Africa and Latin America. San Francisco also has a home-grown tuberculosis problem primarily in the black and homeless communities.

Since implementing the pilot test, SFGH doctors saved one patient from being hospitalized and expedited the discharge of another, Dr. Annie Luetkemeyer said.

Data is pending on how much the new test reduces a patient’s isolation time, but doctors anticipate it will be more than 36 hours.

The pilot program will run through June, though the hospital hopes to continue the testing.

MeMed, Ltd., today announced publication of the results of a large multicenter prospective clinical study that validates the ability of its ImmunoXpertTM in-vitro diagnostic blood test to determine whether a patient has an acute bacterial or viral infection. The study enrolled more than 1,000 patients and is published in the March 18, 2015 online edition of PLOS ONE. Unlike most infectious disease diagnostics that rely on direct pathogen detection, MeMed's assay decodes the body's immune response to accurately characterize the cause of the infection.

Bacterial and viral infections are often clinically indistinguishable, leading to antibiotic overuse and contributing to the spread of antibiotic resistance, which the World Health Organization says is approaching crisis proportions. Paradoxically, the inability to rapidly differentiate infections also results in the underuse of antibiotics, estimated to occur in 20-40% of all bacterial infections, putting patients at risk of complications and increasing healthcare costs. MeMed researchers developed the ImmunoXpert test to accurately distinguish between bacterial and viral infections, with the goal of improving patient management by providing physicians with information that enables them to reduce both the overuse and underuse of antibiotics.

Eran Eden, PhD, CEO of MeMed, noted, "Antibiotic misuse is a pressing public health concern, with devastating healthcare and economic consequences. Rapid, accurate and actionable diagnostic tools are an important part of the solution because they can aid physicians in making better informed treatment decisions. For the past four years, our team has been collaborating with leading clinicians and scientists from around the world to develop and validate our novel approach for distinguishing between bacterial and viral infections. Unlike most traditional diagnostics, this approach builds on an exquisitely informative system crafted by nature – the human immune system. Our scientists have figured out how to decode the actions of the immune system doing what it does best--detecting and responding to the precise cause of infection."

MeMed's technology leverages the fact that bacteria and viruses trigger different pathways in the immune system. By conducting extensive screening of immune system proteins in patients with acute infections, researchers identified three soluble proteins that are uniquely activated by bacteria or viruses. They then developed proprietary algorithms that integrate these proteins to produce an immune signature that accurately identifies the cause of infection.

In the PLOS One study, the ImmunoXpert immune signature was developed and independently validated on a cohort of 1002 patients with acute infections and yielded highly accurate results, with sensitivity and specificity greater than 90%. The assay was validated in a diverse group of pediatric and adult patients at different time points after the onset of symptoms (from the first day up to 12 days) and across 56 different pathogen species. ImmunoXpert remained robust over all sub-groups studied. The predictive power of the assay's immune signature outperformed routine biomarker and laboratory tests, as well as combinations of these tests. The signature is amenable to rapid measurement using a blood test run on standard hospital and laboratory-deployed automated platforms, or using a point-of-care device now in development. "We conducted big data filtering, followed by extensive screening of 600 immune system-related proteins," said Kfir Oved, PhD, MeMed CTO. "A few of the proteins showed distinctly different patterns in bacterial and viral infected patients. In particular, the most informative protein we found, called TRAIL, dramatically increased in the blood of patients infected with a wide range of viruses, but surprisingly, decreased in bacterial infections. Our team developed an algorithm that computationally integrates TRAIL with other immune proteins to diagnose the cause of the infection with high accuracy."

The ImmunoXpert immune-based approach overcomes inherent limitations of many traditional diagnostics tools. It is accurate and rapid, it can diagnose infections that are not readily accessible such as pneumonia (because immune system components circulate throughout the entire body), and it prevents false alarms due to the benign presence ("carriage") of potentially pathogenic bacteria and viruses that are not causing active disease.

"This study represents a breakthrough in our efforts to develop more accurate, rapid and actionable diagnostic tools that improve the management of patients with acute infection." said Professor Isaac Srugo, MD, Head of the Pediatric Department and Microbiology Lab at Bnai Zion Medical Center. "The incorporation of novel viral-induced proteins, currently not in clinical use, enables ImmunoXpert to attain high levels of accuracy, which can help physicians make better informed antibiotic treatment decisions. This should result in more bacterial infected patients receiving timely therapy that is actually useful for treating their illness. Additionally, it can lead to fewer prescriptions to viral patients for whom antibiotics do nothing to speed recovery, while causing potential harm to the larger community."

MeMed's ImmunoXpert test is CE marked and approved for clinical use in the European Union and Israel. It is currently in pilot distribution in these territories, with a broader commercial roll-out planned for later this year. Additional clinical studies are underway and the company is planning to conduct clinical trials in the U.S. using a specially-designed point-of-care platform currently in development.

Thursday, March 12, 2015

PositiveID Corporation, a developer of biological detection and diagnostics solutions, today announced that it has successfully completed its first round of testing of its phase II Firefly Dx prototype handheld real-time PCR (polymerase chain reaction) pathogen detection system, and has delivered positive PCR results within 20 minutes. The Company's Firefly Dx testing was performed at standard laboratory volumes and achieved equivalent results to laboratory-based PCR instruments, which can take hours to perform the same PCR process.

The Company previously announced it completed its Firefly Dx PCR design, and it has now completed successful testing on its Phase II breadboard Firefly Dx system, with consistent and repeated detection of each positive challenge. With the completion of the PCR chip design with confirmatory results, the Company is now in the next phase of testing to encompass optimization and a broader spectrum of tests.

"Having recently completed our Firefly Dx breadboard prototype, these initial positive results of our new PCR chip, which could fundamentally change the real-time PCR industry, are very encouraging," stated William J. Caragol, Chairman and CEO of PositiveID. "These test results also validate our approach covered in the PCR chip patent application we just filed. Our Firefly Dx testing and development continues to progress on schedule."

Firefly Dx is designed to provide real-time, accurate diagnostic results in a handheld device, thereby leading to treatment scenarios at the point of need that are not possible with existing systems, which require lab-based equipment and can take hours or even days to provide results. Firefly Dx is targeting the global PCR market, which is projected to reach approximately $27.4 billion this year, according to a Research and Markets' report Polymerase Chain Reaction (PCR) - Products/Tools - A Global Market Watch, 2009-2015. Firefly's applications include point of need monitoring of pathogenic outbreaks (such as Ebola, influenza, etc.), agricultural screening in both domestic sectors and developing countries, and for the detection of biological agents associated with weapons of mass destruction.

According to the announcement, the system is able to detect and identify microbial sources of contamination for production equipment without the need for a sample to be sent to a lab. This allows manufacturers a fast means of ensuring action can be taken for rectification.

The quick readings that the system gives also allow samples to be sent in case of confirmation purposes, as it does not destroy the contaminant with its detection process. There is also an upgradable library as new contaminants are discovered and studied.

The company will be showcasing the system at the Parental Drug Association’s annual meeting that will take place March 16-18 at the Red Rock Casino Resort and Spa in Las Vegas.

Battelle is a research company that develops and designs technology and provides research assistance to government and corporate customers.

Vivione Biosciences Inc., announced today an impressive array of early adopters for its comprehensive suite of rapid microbial tests recently launched in the Oil and Gas Markets through its affiliate, Petro Chemical Bio-Diagnostics (PC Bio). Just five months ago, Vivione introduced its RAPID-B system to the Oil and Gas Industry through PC Bio, and already companies such as Newpark Drilling Fluids, Trican Well Service, Enervest and Newfield Exploration Co. are utilizing these services to gain unparalleled insights into the treatment of damaging oilfield bacteria.

Bacteria related corrosion, well souring, and plugging issues cost exploration and production companies billions of dollars annually. The industry employs cutting edge chemical treatments to combat bacteria in the field, but has lacked advanced microbial testing techniques to accurately diagnose the problem or measure the effectiveness of their biocide treatments. The power of the RAPID-B technology in combination with PC Bio's other microbial laboratory services have begun to catch the attention of independent and major oil operators who want a more accurate and effective approach to combating microbial damage to their producing wells.

Early this year a large oilfield service company made the decision to purchase the RAPID-B System and incorporate it into their fluid testing and water treatment services. That decision has proved to be profitable as just this week they reported that a major E&P company with a market capitalization of over $50 billion hired them to test for bacteria in water and frac fluids in West Texas in order to systematically identify potential points of bacterial contamination throughout all stages of the frac. They deployed their mobile testing lab, collected fluid samples at key points in the process, including analysis of various size proppants and gels. The Rapid-B™ technology was able to provide them with the live bacteria counts within 15 minutes of initiating the test, resulting in identification of several samples with high bacteria levels detected after the biocide treatment. The Rapid-B™ identified quantitative values of live bacteria allowing the service company time to apply additional treatment of biocides before the fluid entered the formation.

Vivione's CEO Kevin Kuykendall said, "The customer response to the results RAPID-B delivers has been extremely positive. Rapid diagnosis and real time monitoring of biocide treatment effectiveness has always been the Achilles Heel in the area of controlling harmful bacteria like sulfate reducing bacteria and acid producing bacteria. With the Rapid-B System and PC Bio's testing services we can now, for the first time get a thorough handle on the problem and address it quickly with confidence. This represents a significant change in the way E&P companies can combat SRBs and APBs and lower their operating costs."
Garett Heath of Newpark Drilling Fluids Canada also shared, "We view PC Bio's service offerings as a powerful tool to help provide better insight into producing wells and fluid sources where bacterial contamination is of a concern. We strive to surpass our customers' expectations by continuously looking for up and coming, innovative testing that will provide meaningful data to increase our efficiencies in remediating microbial contamination of producing wells and water sources. PC Bio's service offering along with Vivione's RAPID-B platform provides a value-added technology that is designed to do both."

In addition to proactively addressing bacteria related damage to well equipment and pipelines, bacteria testing is also necessary in order to recycle and reuse oilfield waters during the hydraulic fracturing process. To effectively reuse flowback water, it must be first analyzed for microbial contamination. If contamination is present, even in low concentrations, the RAPID-B System can detect this condition on the spot, and can confirm the efficacy of the subsequent treatment process with a much greater degree of confidence. PC Bio's suite of technologies brings a quantum leap in speed and accuracy to the entire process from start to finish. Grant Farion, the Technical Supervisor, International R&D, for Trican Well Service said, "We conduct fracturing services in Canada, Russia, Kazakhstan and the US. There is a general trend away from fresh water toward produced and recycled water, which increases the potential for bacteria to be present in the waters we use."

Kuykendall concluded, "Companies like these that are utilizing our services are industry thought leaders in optimizing Oil and Gas operations. To have them adopt PC Bio's suite of testing services and utilize our technology is a strong endorsement that our RAPID-B platform has successfully transferred from its initial setting in the Food Safety Industry to the much larger Energy Industry. With the recent drop in oil prices placing additional pressure on operating margins, it becomes even more important to avoid the costly problems that bacteria can cause. Our RAPID-B System and related services give energy companies a brand new tactic to control costs through precise, rapid and highly relevant information concerning the health of their producing wells."

Tuesday, March 10, 2015

GNA Biosolutions GmbH, a company developing ultra-fast diagnostic instruments for human pathogens, announced today the start of the FILODIAG (Filovirus Diagnostics) project for developing an ultra-fast Ebola detection system based on GNA’s novel Laser PCR technology. GNA is leading a consortium of the Mendel University in Brno (Czech Republic), the Istituto Nazionale per le Malattie Infettive “Lazzaro Spallanzani” (Italy) and the Italian NGO EMERGENCY. The Project Number 115844 of this Ebola+ programme will be funded with EUR 2.3 million by the Innovative Medicines Initiative.

There is an urgent need for fast and accurate diagnostic tests in the current and any future Ebola crisis. The rapid diagnosis of Ebola Virus Disease (EVD) during early and late stage of infection is a decisive step for risk assessment and for guidance to physicians to take the necessary decisions to limit the spread of the infection, and to safely nurse the infected patients. While fast and easy-to-use tests usually rely on immuno-diagnostic approaches, they typically lack high sensitivity and specificity. The gold standard for accurate diagnostics is Real-Time PCR but this procedure requires special laboratory facilities and a long processing time of up to several hours. Aim of the FILODIAG project is to deliver a potentially multiplexed diagnostic system fast enough for point-of-need testing of incoming patients as well as at critical infrastructure checkpoints like airports by withdrawal of blood, or less invasive fluids, such as saliva or urine.

The core technology being used is based on GNA’s laser-heated nanoparticles (Laser PCR) that helps to overcome the time-limiting step of heating and cooling the reaction sample in conventional PCR reactions. GNA have revolutionized this standard procedure by inducing the necessary temperature cycles with laser-heated nanoparticles that can be heated and cooled more than a million times faster than in conventional PCR. GNA has already performed Ebola Laser PCR assays that detect 10 target copies of synthetic nucleotides, corresponding to the Ebola genome sequence, in less than 12 minutes.

Members of the Department of Chemistry and Biochemistry at Mendel University, Brno, will work on integrating the sample preparation with virus-binding magnetic particles. Leading scientist Dr. Vojtech Adam explains: “We will synthesize, characterize and modify the surfaces of nanomaterials to achieve a highly specific binding of viral proteins that will allow for a faster preparation step from patient samples.”

Project coordinator Dr. Lars Ullerich, a Managing Director of GNA, said: “We are working with our international partners to develop a highly sensitive and specific Laser PCR assay based on saliva, urine or blood for Ebola detection. Our proprietary Laser PCR with ten times faster cycles allows us to utilise the gold standard of PCR also in Ebola diagnostic. Together with a label free detection, the test results will be available in less than 15 minutes. Our Pharos400 system can already detect other highly dangerous pathogens within three minutes and a rapid, simple testing workflow will be crucial to deliver effective support in the management of Ebola outbreaks.”

Dr. Antonino Di Caro, director of microbiology, National Institute for Infectious Diseases “Lazzaro Spallanzani”, will test the device and the assay in a biosafety level 4 laboratory in advance of EMERGENCY conducting field testing in their recently established Ebola treatment centre in Sierra Leone.

The FILODIAG project is being funded by the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115844 (http://www.imi.europa.eu/content/ebola-programme ). This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. IMI2 has recently launched the programme Ebola+, in which eight funded projects have been announced, including FILODIAG, and two further projects with a diagnostic focus.

Beer, milk and juices need to be tested regularly in order to assess the quality of the drinks, especially to see if they are suitable for human consumption. A new polymer powder has been invented to help make this process more efficient.

The main risk to beer is from bacteria. Fortunately, beer is a poor and hostile environment for most microorganisms. This is because the ethanol concentration and low pH is below what most bacteria can tolerate for growth. However, if the wrong bacteria are present and have colonized the brew, then a bitter frothy drink can be transformed into a sour tasting, cloudy, off-color, undrinkable beverage.

It is to guard against this that beer, along with other liquids at risk from food-spoilage microbes, is tested throughout the production process. Beer spoilage organisms are either lactic acid bacteria, such as the sort used to make yoghurt, or they are anaerobic bacteria, associated with bad odors.

One problem is that standard laboratory methods require long incubation times in order to produce a meaningful result. These classic methods require a sample of the beer to be filtered through a membrane. The membrane has pores which allow the liquid to pass through, but which are small enough to capture bacteria. The membrane is placed onto agar and the microorganisms allowed to grow, under a defined temperature, for a period of time. This means that the brewer will only know the status of a batch of beer a considerable time after a contamination event occurred.

In a breakthrough in the realm of rapid microbiological methods, scientists based at GEN-IAL from Troisdorf and Fraunhofer Institute for Applied Polymer Research IAP in Potsdam, have jointly created a polymer powder that reduces the time to result down to two days.

With the method, the powder is added to a small sample of beer. The polymer is designed to binds to the surface of the bacteria. If pathogens are present, these can later be removed along with the particles for analysis.

The new compound has yet to be reported to a science journal. Development work is continuing and the researchers are working towards a commercial kit.

PositiveID Corporation, a developer of biological detection and diagnostics solutions, announced that it has filed a new U.S. patent for its Firefly Dx real-time PCR (polymerase chain reaction) pathogen detection system. The patent filing, A Cyclical and Continuous Flow PCR Device, covers a cyclical mechanism of thermal cycling required to complete real-time PCR and deliver results in less than 20 minutes. This brings the Company's total number of patents and patents pending to 17.

Firefly Dx is designed to provide real-time, accurate diagnostic results in a handheld device, thereby leading to treatment scenarios at the point of need that are not possible with existing systems, which require lab-based equipment and can take hours or even days to provide results. Firefly Dx is targeting the global PCR market, which is projected to reach approximately $27.4 billion this year, according to a Research and Markets' report Polymerase Chain Reaction (PCR) - Products/Tools - A Global Market Watch, 2009-2015. Firefly's applications include point of need monitoring of pathogenic outbreaks (such as Ebola, influenza, etc.), agricultural screening in both domestic sectors and developing countries, and for the detection of biological agents associated with weapons of mass destruction.

PositiveID is developing Firefly Dx based on the know-how gained during years of development and $30 million of contract funding from the U.S. Department of Homeland Security for the Company's M-BAND (Microfluidic Bio-agent Autonomous Networked Detector) system, which uses PCR for the identification of airborne bio-threats.

"This patent filing demonstrates the advances we have made in developing and miniaturizing our real-time PCR chip, which is the engine of the Firefly Dx system," stated William J. Caragol, Chairman and CEO of PositiveID. "Based on our years of experience with PCR testing, we are confident that the advanced technology underlying this patent filing brings us another step closer to bringing Firefly Dx to the large PCR market, which is in need of a system that can provide rapid results anywhere, anytime."

Abaxis, Inc., a medical products company manufacturing point-of-care instruments and consumables for the medical, research, and veterinary markets worldwide and providing reference lab services to the veterinary and research markets in the United States, today announced that the Center for Veterinary Biologicals of the U.S. Department of Agriculture (USDA) has cleared its VetScan Anaplasma Rapid Test Kit for the detection of A. phagocytophelium and A. platys in canine whole blood, serum, or plasma samples.

Clint Severson, chairman, president and chief executive officer of Abaxis, said, "The USDA approval of the VetScan Anaplasma rapid test signifies the completion of the first phase of our vector borne disease rapid tests for dogs. Combining this test with the geographically relevant test for Lyme, Ehrlichia, or Heartworm allows the Veterinarian to choose the most appropriate diagnostic tests for their patients while saving both the practice and pet owner significant money. Abaxis will continue to develop cost-effective and relevant rapid tests to aid the veterinarian in diagnosing disease in their patients."

Dr. Rajesh Mehra, director of research and development at Abaxis, said, "The approval of our VetScan Anaplasma Rapid Test Kit allows us to now offer a complete assessment of tick-borne diseases based on our unique blend of novel peptides which are reactive with species-specific antibodies, coupled with targeted amplification on a rapid test format."

Anaplasmosis is a tickborne disease caused by the bacterium Anaplasma phagocytophilum. It was previously known as human granulocytic ehrlichiosis (HGE) and has more recently been called human granulocytic anaplasmosis (HGA). Anaplasmosis is transmitted to humans by tick bites primarily from the black-legged tick (Ixodes scapularis) and the western black-legged tick (Ixodes pacificus). Of the four distinct phases in the tick life-cycle (egg, larvae, nymph, adult), nymphal and adult ticks are most frequently associated with transmission of anaplasmosis to humans. Typical symptoms include: fever, headache, chills, and muscle aches. Usually, these symptoms occur within 1-2 weeks of a tick bite. Anaplasmosis is initially diagnosed based on symptoms and clinical presentation, and later confirmed by the use of specialized laboratory tests.

Corgenix Medical Corporation and Fio Corporation today announced that they are working together to integrate two technological advances to help end the Ebola outbreak in West Africa: a rapid test, backed by the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation, that can detect the virus in minutes; and a mobile device, which is being adapted with further funding from the Gates Foundation, to analyze and upload results directly to a central data system.

Fio is adapting its Deki™ Reader to work with the Corgenix ReEBOVTM Antigen Rapid Test for the Ebola virus, which recently received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) and was listed as eligible for procurement by the World Health Organization (WHO). Combining these technologies will give suspected Ebola patients in the most remote, resource-poor settings, access to automated test results. Results will then immediately be transmitted to Fio’s data system, Fionet™, capturing vital information that is currently missed or delayed.

“This collaboration makes testing more accessible to those at risk and data more readily available to those managing the outbreak, a combination that the Gates Foundation identified and mobilized,” said Dr. Michael M. Greenberg, chairman and CEO of Fio. “The resulting technology will expand the capability to fight Ebola now and strengthen national health systems beyond the current crisis.”

Corgenix researchers on the ground in Sierra Leone have already started using smartphones to transmit images of rapid Ebola test results to the Fionet data system. Together with Fio’s tools for case and contact mapping, this capability offers governments and other organizations responding to the outbreak a way to track the disease in real time.

“We’re taking the fight against Ebola to another level with Fio’s data collection and management, which is critical to the success of rapid testing,” said Douglass Simpson, Corgenix president and CEO. “This marks a tremendous advancement in Ebola testing, and it lays the groundwork for a strong and productive partnership between our two companies on future projects.”

The instant traceability of infected or potentially infected individuals – knowing test results, locations and movement over time and across borders – is essential to containing the spread of the Ebola virus and other highly contagious diseases.

Both companies will continue to work together to integrate the two technologies for decentralized Ebola virus testing throughout West Africa. Beyond the current crisis, this will serve health systems more broadly to better manage future outbreaks, as well as other infectious diseases in the region, such as Lassa virus.

Fio’s Deki Reader – which is already CE-marked for use with rapid tests that detect malaria and dengue fever – is also being adapted for use with the Corgenix ReLASV® Antigen Rapid Test for the Lassa virus.

Fio received a Gates Foundation grant in December 2014 to adapt its Deki Reader to analyze rapid Ebola tests and transmit results to Fionet to be integrated with case and contact management tools.

A few weeks later, Corgenix received two grants – one from the Gates Foundation and one from the Paul G. Allen Family Foundation – to advance the company’s development of an Ebola rapid test kit.

Both the ReLASV® Antigen Rapid Test and the ReEBOVTM Antigen Rapid Test have not been cleared for routine diagnostic use by the U.S. Food and Drug Administration.

The ReLASV® Antigen Rapid Test is CE-marked for diagnostic use in EU and other countries that recognize the CE mark.

The ReEBOVTM Antigen Rapid Test is not CE-marked and may only be used as a diagnostic device under the conditions of the Emergency Use Authorization issued by the U.S. Food and Drug Administration.